FDA Law Blog

OCTOBER 8, 2023

Palmer — On Friday, October 6, 2023, DEA announced a second extension of telemedicine flexibilities concerning the prescribing of controlled substances, which were originally set to expire after the end of the COVID-19 pandemic emergency. By Karla L. comments on the two proposed rules.

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FDA Law Blog

NOVEMBER 6, 2023

is pleased to announce it took top honors in two categories in the 2023 LMG Life Sciences Awards, which recognize the best life science practitioners and firms over the past 12 months from the United States, Canada, and Europe. In addition, other law firms retain HPM to provide targeted expertise in food and drug law to assist their clients.

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FDA Law Blog

NOVEMBER 15, 2022

By Véronique Li, Senior Medical Device Regulation Expert & Philip Won — In our last blog post , we advised medical device companies to consider applying to FDA’s Small Business Program to help with the noticeably higher user fees for FY2023. In this blog post, we provide a primer on user fees and the Small Business Program.

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FDA Law Blog

MAY 19, 2025

For a controlled substance prescription to be effective, that is valid, it must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of their professional practice. Attorneys Office, Northern District of Illinois, April 21, 2025. Complaint, 82. 81, 86, 251. 81, 89, 251.

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FDA Law Blog

JANUARY 5, 2023

Claud — As we turn into the New Year, we offer a few items of interest in digital and telehealth regulation, enforcement, and compliance that may provide some helpful guideposts for stakeholders. Combination products are sharing the digital moment with those classified solely as medical devices. By John W.M.

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FDA Law Blog

JUNE 8, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — On May 11, 2023, the U.S. The pandemic also deeply impacted how industry and the government conduct their operations. The pandemic also deeply impacted how industry and the government conduct their operations.

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FDA Law Blog

AUGUST 8, 2024

Governors, state cannabis regulators, law enforcement groups and local governments weighed in, as did marijuana advocates and opponents, marijuana industry associations, Members of Congress, federal law enforcement groups, healthcare and human rights groups, unions and trade associations, and private individuals. 812(c)(c)(10). 21 U.S.C. §

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FDA Law Blog

MARCH 3, 2024

The LDT rule has moved forward with astonishing speed, advancing from the release of the proposed rule on October 3, 2023 to OMB in less than five months. It remains to be seen whether FDA’s hasty finalization of the rule will provide fodder for APA challenges for failing to adequately address substantive comments.

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FDA Law Blog

SEPTEMBER 17, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — Over the last three and a half years, meetings with FDA were conducted virtually. If FDA is slow in providing that list, it is fine to send a follow-up email requesting a list of FDA attendees in advance of the meeting. Be ready with backup options (e.g.,

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FDA Law Blog

MARCH 24, 2024

The 340B contract pharmacy dispute involves several manufacturers who are refusing to provide 340B discounts to covered entities if they requested 340B drugs to be delivered to, and dispensed from, a network of contract pharmacies. The court also noted that the practice of pharmacy is an area traditionally left to state regulation.

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FDA Law Blog

NOVEMBER 2, 2023

Lewis, Senior Regulatory Device & Biologics Expert — On October 20, 2023, FDA announced the availability of the final guidance authored by CBER titled “Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies.” Tobolowsky & Richard A. It finalized a draft guidance published in 2022.

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FDA Law Blog

JUNE 27, 2024

After issuing an Order to Show Cause and Immediate Suspension of Registration in September 2022, and an administrative hearing in March 2023, DEA adopted the hearing Administrative Law Judge’s (“ALJ’s”) Recommended Decision to revoke Coconut Grove’s registration based on the public interest factors of 21 U.S.C. 21 U.S.C. § 21 U.S.C. §

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FDA Law Blog

AUGUST 17, 2022

This is important because self-fitting hearing aids require the submission and clearance of a 510(k) while regular OTC hearing aids do not, which provides incentive for manufacturers to self-classify their hearing aid products as regular OTC rather than self-fitting. (FYI, The preemption provisions, for example, have not changed.

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Medical Xpress

JUNE 16, 2025

This region governs essential behaviors like the circadian clock, sleep, energy balance , and feeding. The content is provided for information purposes only. But technical limitations have made it hard to understand how neurons in this area form functional circuits."

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ABIM

MAY 30, 2025

Lieske, MD , raised concerns about how new government policies may affect international medical graduates and health equity work at ABIM. One notable trend was a higher representation of international medical graduates and osteopathic physicians in the specialty. Community Practice in ABIM Governance* Erica N.

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FDA Law Blog

OCTOBER 17, 2023

Compared to the previous version, the new guidance document highlights that the Breakthrough Devices Program may also be applicable to certain devices that benefit populations impacted by health and/or healthcare disparities and to certain non-addictive medical products to treat pain or addiction. By Philip Won & Lisa M. 360e-3)).”

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FDA Law Blog

APRIL 8, 2024

MRAP would provide oversight of an accreditation body which would conduct assessments—paid for by the manufacturer—based on criteria developed by the MRAP. Unfortunately, the White Paper does not provide further analysis on the generic sterile injectables and instead refers back to FDA’s analysis from 2013-2017. In Section I.A,

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FDA Law Blog

NOVEMBER 21, 2024

DEA notes in the Federal Register notice that it received over 38,000 comments to its 2023 proposed rules (35,454 for the general telemedicine flexibilities proposed rule and 2,915 for the buprenorphine telemedicine flexibilities proposed rule), and held two days of public listening sessions addressing industry comments.

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GeriPal

MARCH 24, 2023

JAMA IM 2023 A shout-out to my NPR episode on 1A titled the “State of Hospice Care” DISCLAIMER While we filmed in Montreal during the Annual Assembly, all opinions expressed in this podcast are independent of AAHPM and HPNA, or the Annual Assembly. She happened to focus on some specific for-profit hospice providers. JAMA Health Forum.

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GeriPal

MARCH 6, 2025

link] Toronto Star Feature [link] CityNews Toronto Feature [link] Psychosocial Interventions at PEACH In addition to medical care, PEACH also runs two key psychosocial interventions for our clients: PEACH Grief Circles Structured spaces for workers in the homelessness sector to process grief. those experiencing homelessness).

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FDA Law Blog

JUNE 2, 2023

Kirschenbaum — Last Friday, May 26, CMS published in the Federal Register an assortment of proposals to change the regulations governing the Medicaid Drug Rebate Program. The preamble provides an example of reporting an incorrect baseline AMP, which reduces the unit rebate amount. Sheldon, v.

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GeriPal

SEPTEMBER 5, 2024

And he’s also chaired the California Pacific Medical Center’s ethics committee since 1985. Louise 05:02 Yes, well, I don’t know about 2024, but in 2023, yes, it could happen. And it’s not the same, but it does provide information. Bill, welcome to the GeriPal podcast. Bill 00:53 Thank you, Alex.

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FDA Law Blog

AUGUST 14, 2022

The negotiations will result in a Maximum Fair Price (“MFP”) that the manufacturer must make available to providers furnishing the drug under Medicare Part B or pharmacies dispensing the drug under Part D. The same will be required under state Medicaid and CHIP programs by October 1, 2023.

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FDA Law Blog

FEBRUARY 11, 2024

The three letters together provide the range of actions DEA may take: no rescheduling from schedule I (former drug officials), rescheduling to schedule III (Democratic state attorneys general), or descheduling altogether (Democratic senators). (We We blogged on the December 5, 2023, letter from six Democratic governors to President Biden).

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GeriPal

AUGUST 15, 2024

We discuss: What is considered a hate incident, how is it tracked, what do we know about changes over time The wider impact of Anti-Asian hate on older Asians, who are afraid to go out, leading to anxiety, social isolation, loneliness, decreased exercise, missed appointments and medications. question used to screen for domestic violence.

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FDA Law Blog

JANUARY 24, 2024

Section 1 of the Executive Order laid out the Biden Administration’s policy to, among other things, “coordinate a whole-of-government approach to advance biotechnology and biomanufacturing towards innovative solutions in health, climate change, energy, food security, agriculture, supply chain resilience, and national and economic security.”

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GeriPal

DECEMBER 21, 2023

Don’t get me wrong, the evidence points to cost savings, but as Chris Callahan and Kathleen Unroe pointed out in a JAGS editorial in 2020 “in comprehensive dementia care models, savings may accrue to Medicare, but the expenses accrue to a fluid and unstable network of local service providers, patients, and their families.”

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GeriPal

APRIL 20, 2023

In the United States in 2023, the truth of the matter is you don’t need very many individual risk factors to become homeless. In what moral universe is a federal government deeply subsidizing my housing and not subsidizing that of my patients? What medical intervention saves health dollars, costs less than not doing it?

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Common Sense Family Doctor

APRIL 25, 2025

population, and a near-doubling in outpatient visits to advanced practice providers (the majority of whom work in medical subspecialties) wasn't enough to make up for this deficit. I'm an example of this pattern, having intended to become a pediatrician when I started medical school.) growth in the U.S.

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Physician's Weekly

JUNE 12, 2025

An “improper” payment refers to payments made erroneously to beneficiaries and their providers or without sufficient documentation. In a 2024 report covering the years 2022, 2023, and 2024, Medicaid’s parent agency — the Centers for Medicare & Medicaid Services — said the rate was about 5.1%.

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The Clinical Problem Solvers

MAY 2, 2023

[link] CPSolvers: Antiracism in Medicine Series Episode 21 – Psychosocial and Cultural Considerations for Providing Healthcare to Immigrant and Refugee Populations Show Notes by Kiersten T. Many organizations, such as the American Medical Association Journal of Ethics, recommend against documenting immigration status in medical records.

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Physician's Weekly

JUNE 26, 2025

In the medical odyssey that followed, she suffered double vision, chronic nausea, brain fog, and profound weakness. People with covid vaccine injuries, however, are stuck in a kind of limbo, often without clear medical options. Once a rock climber, she became a couch potato. It has paid out about 12,000 awards worth a total of $4.8

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FDA Law Blog

JUNE 1, 2025

Government Accountability Office (GAO) published a report finding that, for the years 2016-2018, the pharmaceutical industry spent on average for a sample of 553 drug products approximately $6 billion annually on DTC advertisements, with a significant portion of this spending allocated to television commercials. In 2021, the U.S.

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GeriPal

JULY 20, 2023

See the AAHPM Legislative Action Center [link] Write to the DEA, with guidance from AAHPM’s comments to the DEA March 2023. Alex: We are delighted to welcome Joe Rotella, who’s the Chief Medical Officer of the American Academy of Hospice and Palliative Medicine. What was life for you as a provider pre-pandemic?

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Physician's Weekly

JUNE 25, 2025

Dangerous changes loomed: To compensate for tax cuts for the wealthy, Trump’s “big, beautiful” bill and budget proposal for fiscal year 2026 threaten to curtail Medicaid, which provides health coverage for people with low incomes and disabilities. In the 1980s, the government refused to acknowledge HIV as gay men died young.

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FDA Law Blog

MAY 23, 2025

During the first Trump Administration, the 10-for-1 Rule seemed to be more in name only when it came to FDA, whereas this administration seems more intent on its deregulatory approach, so we expect it to have more of an impact on FDA governance this time around. Radical Transparency. Deregulation Efforts.

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FDA Law Blog

MAY 26, 2025

Specifically, these are procedures and drugs used in providing what HHS had, until recently, referred to as gender-affirming care. Department of Health & Human Services purporting to provide a comprehensive review of the evidence and best practices for promoting the health of children and adolescents with gender dysphoria.

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